Study to Evaluate the Use of Palifermin to Treat Toxic Epidermal Necrolysis

• Status: Terminated
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

To test the ability of palifermin (a recombinant human keratinocyte growth factor) to decrease mucocutaneous injury and to promote epithelial repair in Toxic Epidermal Necrolysis and Stevens-Johnson Syndrome-Toxic Epidermal Necrolysis Overlap, diseases in which there is extensive sloughing of the skin and mucosa, including that of the eyes, gastrointestinal tract, respiratory and genitourinary systems.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brett King
• Collaborator: Swedish Orphan Biovitrum

Criteria

Inclusion Criteria:

• Skin biopsy in early disease showing apoptotic keratinocytes in the epidermis and in more advanced disease necrosis of the entire epidermis

• Epidermal detachment or erythematous to purpuric macules involving more than 10% of body surface area in addition to involvement of the oropharynx; there may be further involvement of other mucosal surfaces, ie. conjunctivae, gastrointestinal tract, respiratory and genitourinary epithelia

• Age of 18 years old or older

• The patient is expected to survive longer than 48 hours

Exclusion Criteria:

• Skin detachment above 90% of the body surface area

• Skin detachment has not progressed during the previous 48 hours

• A positive serum pregnancy test

• Age < 18 years old

• Known hematologic or solid organ malignancy